MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA RIST; CATHETER, PERCUTANEOUS, NEUROVASCULATURE

Model Number	106F-071-95
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Codes	Vasoconstriction (2126); Foreign Body In Patient (2687)
Date of Event	07/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report that when the hospital / lab was done with stroke treatment and trying to remove the rist catheter, it fractured.A vascular surgeon tried pulling it out from the wrist but it did not work.The interventional team went through the groin and tried to snare the rist but this also did not work.The distal tip of the rist broke off from the catheter.The rist catheter remains in the patient.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: RIST
• Common Device Name: CATHETER, PERCUTANEOUS, NEUROVASCULATURE
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine,ca
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine,ca
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; +1(763)526-5677
• MDR Report Key: 50126702
• Report Number: 2029214-2026-01468
• Device Sequence Number: 5674502
• Product Code: QJP
• UDI-Device Identifier: 00763000541194
• UDI-Public: (01)00763000541194(17)290405(10)29715-01
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K211990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 106F-071-95
• Device Catalogue Number: 106F-071-95
• Device Lot Number: 29715-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/10/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Supplement Date Received by Manufacturer: 08/05/2026; 08/30/2026
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 08/28/2026; 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 168 LB